Luye Pharma Group said its injectable risperidone schizophrenia drug was given the go-ahead for a new drug application (NDA) from the U.S. Food and Drug Administration with no additional clinical trials needed, according to a report by China Daily.
The paper reported that this is the first "self-developed innovative" drug from China that will enter the U.S. market "in the near future" and the move will "significantly" cut costs and the time spent obtaining final FDA approval.
The drug is produced as "extended release microspheres for intramuscular injection" and the company says it should help improve regimen compliance because it is injected only once every two weeks, China Daily reported.
The company said the FDA confirmed that the results of a previous study with 108 patients in the U.S. can be used to support its NDA application, which is currently being prepared by the company, China Daily reported.
In addition to the U.S., the company is preparing to get approval for the new drug in Japan and Europe and is developing other undisclosed products for those three markets that are being developed in China. Previous reports said the company's risperidone could be launched as early as 2017 in the U.S.
- here's the story from China Daily